A few ideas for Patient Partners helping to inform, shape and influence health and social care research
The first rule has to simply be – get comfortable! A cup of coffee or tea to hand.
I look for the Lay Summary – it will be there somewhere. I still prefer to print of a paper copy of this page although I am getting better at using tools like track changes for reviewing.
These Lay Summaries are improving all the time! It is a very long time since I have seen the exact copy of the scientific summary with the remark – “I cannot make this simple!” Bless them!
I like to use a pencil with an eraser as I change my mind – a lot! I have a quick read and mark lightly with an underline or circle of phrases I don’t understand.
I take another sip of my drink then read more slowly trying to avoid turning to a dictionary or typing into the computer the medical terms.
I have to remember why I am doing this and what my role is as ‘the patient’ (I could easily be a carer, service user or member of the public) is all about. I am there to provide an additional set of eyes and think what I might understand if given this to read as a study participant.
I also have to stay calm and relaxed as this can be a frustrating task (for the researcher and us). I breathe in deeply before my next read and promise myself a reward (biscuit or cake) when I complete this stage.
I always have to remind myself that I am there to assist and help the researcher understand their work from my perspective; to ensure that it is about improving these pages so that they make sense.
It is not necessarily about doing the writing for the researcher – it is about doing it with them. Imagine your teachers just giving you the answer – “Please Miss, Please Sir – what’s the answer?” says the learner. “Here, let me do it for you!” say the teacher. If this is what occurs then ask yourself if any actual learning has taken place.
Reading and Reviewing these papers is fundamentally about learning from each other. I like to think about it as taking the researcher for a walk so that they get a sense of my experience and I get a sense of theirs.
OUR UNIQUE PERSPECTIVE
My experiences are much more than the events told in the order they happened. They are about me drawing upon and selecting the most appropriate moments for the study. They are about me reflecting and using these experiences to help the research improve people’s health and treatments
My treatments (7 weeks radiotherapy on my throat) left me with few saliva glands so that experience makes me look for possible side effects, longer term problems and think about how research might make a difference for future patients. I move from bringing hindsight, to offer insight that might provide foresight.
It is right that we are involved in this way. For years we were the missing presence at the table, the missing voice in the room and the unaccounted – apart from being a statistic or just the research subject.
Involving patients and the public in research has had a huge impact on research practice and culture.
Our biggest advantage is not knowing the science, medicine, research and even when we do begin to understand, how we came through the door is so vastly different from the researchers who chose to be there.
I sometimes say that I have lived in another country happily for many years but it does not stop me being from a different place. It is what I learn from each of these that makes me who I am. However, it is much better to ask someone living in that country today for a current opinion.
I would therefore encourage many patient advocates to think about encouraging and promoting the involvement of patients rather than just being the ‘patient voice’ especially as they become so familiar.
In essence, it is those external eyes, the other and most recent view that provides the picture that is required.
I include these just in case there is any confusion or if you are just staring off on this task of reading and commenting upon them.
Protocol – This is the document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organisation of a clinical trial,) and ensures the safety of the trial participants and integrity of the data collected.
Patient Information Leaflet – This explains to individuals everything that will happen to them, should they consent to participate; it allows them to weigh up the risks and benefits of taking part; and it ensures that the information provided to them is fully documented from a legal perspective. All of the above should be achieved in as concise a way as possible, without compromising clarity.
Lay Summary – This is a brief outline of a research project that is used to explain complex ideas and technical and scientific terms to people who do not have prior knowledge about the subject.
Consent Form – This provides potential research participants sufficient written information to decide whether to participate in a research study or not based on an explanation of the proposed research and the nature of the participation that is requested of them. It is signed to witness the agreement to take part.
Our experiences can add value to research in many different ways. It can ensure that the research question that is being asked is…
Relevant – Is this the type of study that meets the needs of patients/carers and therefore might they be keen to take part.
Understandable – Will the person being asked to take part be able to understand the language, structure, content, the medical terms, the jargon. This is not about simplifying the words – it is about distilling and crystallising what it means. It is far from easy.
Possible – Is this a study that can you can imagine being done or might participants think it not practical in terms of how we are feeling.
Suitable – How does this study fit in with other aspects of our lives, the extra hospital visits, the tiredness, etc.
Appropriate – Lastly, does it seem the right thing we should be doing.
These are all about reality checking, grounding the research in the real life circumstances that patients are in. That is what our experiences teach us and that we can bring to the table.
Of course, a researcher is perfectly entitled to hear everything we have said and still be of the opinion that the research is still important enough to be carried out. I just want them to explain why the is.
THE LAND OF RESEARCH
Many researcher carry out this work as an extra to their day job. It is a highly competitive environment with significant pressures. Gaining funding can take years. Research, unsurprisingly, has its own language, culture and rigorous methods. It is necessarily highly complex and complicated.
This can, at times, separate research into a separate bubble – an academic silo.
It can feel like you have entered another country but remember our role is to help them understand our experiences not for us to become like them.
With a Research Protocol, I begin by flicking through the whole document and skim reading odd bits here and there. I am trying to get a grasp of content and where the different bits are. I am hoping to gain sense of the purpose, the layout of the document and which pages I will need to read thoroughly. I might get an impression of how much time it might take to review. I may want to delay but the likelihood is that the researchers wants it back later today.
I note relevant ‘patient/participant’ sections; actual mention of patients – i.e. the incidence/need, the reason for research; the Lay Summary; whether those who are intended to benefit have been actively involved already (rather than proposed in the future) and what difference that has made; I look for the costs for involvement and see if the cost calculator has been used; I look for the Patient Info Leaflet and the Consent Form if included.
I also look for aspects of inclusion, equality and diversity. In particular to see if this research might effect certain groups or communities. This now has greater significance since Covid-19 and the events surrounding Black Live Matter. It might also affect vulnerable groups, rare diseases, young people, sexual health, etc. See previous blog post on Inequalities
The UK Health Research Authority has very recently published its Transparency Strategy which requires research to be recorded and reported back to those who who took part. As we review these documents we need to ask how this will be achieved.
ABOUT THE RESEARCH
My next task is to understand the need for study. To see how clearly this is explained. As a learner, I am perhaps also looking to understand the science, the medicines and the research methods that are being used. Is it for example a quantitative study counting the difference or a qualitative study capturing the experiences? Might it have an element of both?
What might this mean for the participant? Does the burden of the being on the study outweigh the benefit?
It is at this point that I am beginning to highlight words, phrases and the way things are said with those headings of relevance, understandability, possibility, suitability and appropriateness.
I have now reached the point where I begin the actual review but more of that later.
Time for a treat, I think…
Note: This was prepared in readiness for an Online Workshop at The Royal Marsden for Dr Markella Boudioni, Patient & Public Involvement & Engagement Lead
SOURCES of INFORMATION
About Trials in General